JP2999165B2 - Stent supply device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a delivery system for delivering and deploying a stent to a treatment site in a lumen of a living animal or living human body.

[0002] The delivery system of the present invention provides for complete removal and insertion of a detachment catheter as typically required in the prior art, prior to deployment of the stent and, if desired, after deployment of the stent. Without a balloon catheter to dilate the lumen.

[0003]

FIG. 1 is an overall view of a stent supply device useful for practicing the present invention. FIG. 2 shows part 2 of FIG.
It is the figure which expanded the part which shows the detail of. FIG.
FIG. 2 is a longitudinal cross-sectional view of the distal end of the device of FIG. 1, showing the inner and outer catheters, the stent in a collapsed radially inward position, and the balloon supported and squeezed by the device. FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. FIG. 5 is a perspective view of a portion of the device of FIG. 3, showing the balloon inflated. FIG. 6 is a view similar to FIG. 3, but showing the outer catheter partially retracted and the stent partially deployed. FIG. 7 is a view similar to FIG. 4, but showing the stent fully deployed, the outer catheter returned to the position shown in FIG. 3, and the balloon inflated upon inflation after deployment.

[0004] With reference to these figures, and in particular to Figures 1-3, a stent delivery system or medical device 10 can be seen. The system or device 10 includes a proximal end 14
And an inner catheter 12 having a tip 16. The system 10 further includes a proximal end 22 and a distal end 2.
4 as well. The outer catheter 20 is disposed around the inner catheter 12 and forms a tubular space between the inner catheter 12 and at least the distal ends 16 and 24 of the outer catheter 20. Apparatus 10 also includes an inflation balloon 26 disposed about the outer catheter and secured by conventional means. In addition, the device 10
The distal end 24 of the outer catheter 20 and the inner catheter 12
It also has a stent 30 located in said tubular space 18 between the distal end 16 of the stent.

The device 10 also has a valve or manifold 32 secured (by conventional means) to the outer catheter 20. The manifold 32 includes a through lumen 34 that is aligned with the through lumen 36 of the outer catheter 20.
have. A flushing port 38 is formed as part of the manifold 32 and is in fluid communication with the tubular space 18 when the lumen 34 and the internal catheter are received in the device 10. The flushing port 38 is used to introduce a flushing fluid or a fluid-coated activating fluid (such as a saline solution) or, if desired, a conventional lubricating fluid into the tubular space 18. Is also good. The flushing liquid is useful to extinguish the air in the tubular space 18 and reduce the likelihood of air embolism there. Valve 32
Also preferably has a bulged portion 40 in fluid communication with an auxiliary or second lumen of the outer catheter 20. Referring now to FIGS. 4 and 5, an auxiliary or second lumen 42 allows fluid to pass between the balloon 26 and the outer catheter 20 to the inflation space 44 via a skive 46. Is joined to.
A guidewire (not shown) may be inserted into the lumen 28 of the inner catheter 12 and, if desired, into the lumen 34 of the manifold 32 so as to extend through the tip 50.

[0006] The distal end of system 10 is constructed of a flexible elastomeric material to provide a relatively streamlined entry surface for the stent delivery system to facilitate insertion into a body lumen. Is preferred. FIG.
As can be seen most clearly, a pair of radiopaque band members 52, 54 are preferably located at the proximal and distal ends of the stent, respectively. These band members 52,54 may be used to assist in positioning the radiographically assisted or directed stent 30 within the lumen 60, for example, as shown in phantom in FIGS. It provides a clear boundary at the 30 ends. The balloon is provided axially within the band members 52, 54 such that the band member provides an indication of the position of the balloon for the purpose of positioning the balloon at the desired inflation location. In some embodiments, the radiopaque band member comprises:
Defining the proximal and / or distal end of the balloon.

[0007] The stent 30 of the delivery system 10 is preferably of a self-expanding type that is supported in a collapsed state between the inner catheter 12 and the outer catheter 20. Hans I. Wallsten as inventor
Reexamined US Patent No. 4,655,7
No. 71B1, "Prostheses with Expandable or Contractible Tubular Body", is hereby expressly incorporated by reference as an example such as a self-expanding prosthesis or stent.

[0008] The balloon 26 is preferably located directly outside the outer catheter 20 and radially outside the stent 30. In use, the device 10 can be placed at the treatment site (typically with or without the use of band members 52, 54, using radiographic techniques).
Preferably, the distal end 16 supporting the stent 30 is positioned and then manipulated to inflate the balloon 26 to expand the lumen 60 and then deflate the balloon 26. The balloon 26 is connected to the external catheter 20.
Is expanded or pressurized (typically by injecting a saline solution through inflation port 40) using another second lumen 42 at.

Next, the outer catheter 20 is retracted (after the balloon 26 is deflated by withdrawing the saline solution through the port 40) while the inner catheter 1 is retracted.
The second position is maintained so that the stent 30 is deployed at the treatment site. Alternatively, the distal portion 16 may be located slightly distal of the treatment site to allow fine proximal movement of the stent 30 during deployment. The inner catheter 12 has a stent 30
In order to inhibit axial movement of the stent 30 when retracted during deployment of the stent, a radially outwardly facing stop or stop member disposed adjacent the proximal end of the stent 30 (in the illustrated embodiment, (Combined functionally with a radiopaque band member 52).

[0010] Finally, the device 10 is withdrawn with or without the distal catheter 20 distally from the lumen or tube 60 toward the distal end 50. It should be noted that the pre-deployed inflation of balloon 26 may be omitted if desired. Further, the external catheter 20
May be moved to position the balloon 26 radially inside the stent 30 and, if desired, inflated after deployment of the stent 30, as shown in FIG. The balloon 26 is then deflated and the device 1
0 is withdrawn from the lumen.

Accordingly, the present invention is directed to a method of using a combined stent and an apparatus for expanding a partially occluded portion of a body lumen and deploying the stent there, comprising the steps of: Including providing the device without having to remove the device in between. Here, the task is to partially expand the occluded portion of the body lumen using a balloon supported at the distal end of the device, and to release the stent at the expanded portion of the body lumen. And retracting an outer sleeve or catheter covering the self-expanding stent. According to one aspect of the method of the present invention, in certain procedures, the distal region of the delivery device is slightly distal to the treatment site prior to deployment of the stent so that the stent is deployed at a desired location relative to the treatment site. Preferably, they are arranged.
This allows for some proximal movement during deployment at certain locations due to the known tendency of certain self-expanding stents.

More specifically, the method includes inserting the stent delivery device 10 into the lumen 60. The device includes a self-expanding stent 30 supported in a collapsed condition between the inner and outer catheters 12, 20 and limited in proximal axial movement by a step or member 52. In addition, the device 10 is further all
Balloon 2 supported thereon in the distal region of
6. The method also includes manipulating the device 10 to position the stent 30 at a treatment site, typically a partially occluded portion of the lumen 60,
There, the outer catheter 20 is retracted and the device 10 is deployed so that the stent 30 is deployed at the treatment site.
Is then withdrawn from the lumen 60.

[0013] Another aspect of the method of the present invention is the stent 3
Before deploying the stent 30 after maneuvering the device 10 for positioning the O at the treatment site, the method includes the steps of positioning the balloon 26 at the treatment site and inflating the balloon 26. Still another (optional) aspect of the invention is advancing the outer catheter 20 distally to position the balloon 26 inside (radially inward) of the stent 30 at the treatment site; Inflating the balloon 26 within the stent 30 (to further inflate or deploy) and then deflating the balloon 26. In this case, all of these steps are performed prior to withdrawing device 10 from lumen 60 after stent 30 has been deployed. Of course, it should be noted that balloon inflation or lumen dilation both before and after deployment can be used in the practice of the present invention.

The invention is not to be construed as limiting in all of its details, and modifications and variations thereof can be made without departing from the spirit and scope of the invention.

[Brief description of the drawings]

FIG. 1 is an overall view of a stent supply device useful for practicing the present invention.

FIG. 2 is a partially enlarged view showing details of a part 2 in FIG. 1;

FIG. 3 is a longitudinal cross-sectional view of the distal end of the device of FIG. 1, showing the inner and outer catheters, the stent in a collapsed radially inward state, and the balloon supported and collapsed by the device. I have.

FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 3;

FIG. 5 is a perspective view of a portion of the device of FIG. 3, showing the balloon inflated.

FIG. 6 is a view similar to FIG. 3, showing the outer catheter partially retracted and the stent partially deployed;

FIG. 7 is a view similar to FIG. 4 showing the stent fully deployed, the outer catheter returned to the position shown in FIG. 3, and the balloon inflated in the inflated state after deployment.

[Explanation of symbols]

 Reference Signs List 10 stent supply system (medical device) 12 internal catheter 14 proximal end 16 distal end 18 tubular space 20 external catheter 22 proximal end 24 distal end 26 inflation balloon 28 lumen 30 stent 32 manifold 34 penetrating lumen 38 flushing port 40 Inflation port 42 lumen 44 interior 50 tip 52,54 band member 60 lumen

Continuation of front page (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 29/00 A61M 25/00

Claims (13)

(57) [Claims] 1. a) proximal end (14) and distal end (16)
An inner catheter (12) having a proximal end (22) and a distal end (24), disposed around the inner catheter, and having a distal end and a distal end of the inner catheter. An outer catheter (20) defining a tubular space therebetween; c) an inflation balloon (26) disposed around the distal end of the outer catheter; d) a distal end of the outer catheter and a distal end of the inner catheter. A medical device (1) comprising a stent (30) disposed in a tubular space between
0). 2. A radially outwardly-facing member (52) adjacent to a proximal end of the stent to inhibit axial movement of the stent when the outer catheter is retracted. 2. The device according to claim 1, wherein: 3. Apparatus according to claim 2, wherein said member comprises a first radiopaque band member (52). 4. The device of claim 3, further comprising a second radiopaque band adjacent the distal end of the stent. 5. The device according to claim 1, wherein the stent is a self-expanding stent. 6. The tubular space between the inner catheter (12) and the outer catheter (20) comprises the stent (3).
6. Device according to claim 5, characterized in that the device is sized to keep 0) in a radially collapsed state. 7. A flushing port (38) coupled to allow fluid to pass through the tubular space between the inner catheter and the outer catheter; ii) a flushing port to permit inflation of the balloon (26). Apparatus according to any of the preceding claims, further comprising a manifold (32) having an inflation port (40) coupled to pass fluid through the two lumens. 8. The apparatus of claim 7, wherein said manifold further comprises a through lumen allowing passage of a guidewire therethrough. 9. A) proximal end (14) and distal end (16)
And at least a lumen (2) at its distal end (16).
8) forming an inner catheter (12), b) being disposed around said inner catheter (12), forming a tubular space (18) between said inner catheter (12) and its distal region ( An outer catheter (20) having an inflation balloon (26) disposed about 24) and a lumen (42) coupled to allow fluid to pass through the interior (44) of the inflation balloon (26); c) a stent delivery system (10) comprising a stent (30) disposed in the distal region of the device in a tubular space between the inner catheter (12) and the outer catheter (20). . 10. The inner catheter (12) further comprises a tapered tip (50) at the end of its tip (16).
The stent delivery system (10) according to claim 9, comprising: 11. The stent delivery system (10) according to claim 9 or 10, wherein the balloon (26) is located radially outward of the stent (30). 12. The balloon of claim 9, wherein the balloon is inflatable to inflate the lumen containing the device prior to deployment of the stent. Item 12. A stent delivery system (10) according to any of the preceding items 11. 13. The inner catheter (12) and the outer catheter (20) are pulled out of the inner catheter (12) by withdrawing the outer catheter (20) from the distal end (16) of the inner catheter (12). 13. The stent delivery system (10) according to any of claims 9 to 12, being releasable from a tubular space (18) therebetween.